Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

ConditionsPostoperative Pain Analgesia Supratentorial Brain Tumor

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorBeijing Tiantan Hospital

About this trial

Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged from 18 to 65 years

American Society of Anesthesiologists physical status I to III

Scheduled to undergo elective supratentorial tumor resection

Disqualifiers

Incision-area skin infection

A history of previous craniotomy

Allergy to study medications

A history of preoperative change in consciousness or cognitive function

Trial design

Design model

Factorial

Treatments tested in this trial

Dexmedetomidine
Drug
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery.
Normal saline
Drug
In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group
Local analgesic techniques
Other intervention
As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine
no Local analgesic techniques
Other intervention
No Local analgesic techniques will be given.

Treatment groups

2,000 Participants

are divided into 4 treatment groups

Group A: Local analgesic techniques + dexmedetomidine groupExperimental treatment 2 interventions

Group B: Local analgesic techniques and placebo dexmedetomidine groupExperimental treatment 2 interventions

Group C: Placebo local analgesic techniques and dexmedetomidine groupExperimental treatment 2 interventions

Group D: Placebo local analgesic techniques and placebo dexmedetomidine groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.

Time frame

48 hours postoperatively

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: